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Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02824926
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Collaborator:
Biolab Sanus Farmaceutica
Information provided by (Responsible Party):
Gilberto De Nucci, Galeno Desenvolvimento de Pesquisas Clínicas

Brief Summary:
This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment, treatment and follow-up visits. Treatment period is 14 days.

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: Dapaconazole Drug: Ketoconazole Phase 2

Detailed Description:
The study sample consists of male and female subjects aged between 18 and 60 years-old, either with single or multiple Tinea Pedis lesion(s). Sixty (60) patients will be enrolled, but each foot with lesion(s) will be considered as one (1) sample. Therefore, if a patient has bilateral lesions, one foot will be allocated to investigational product (Dapaconazole) and the other foot will be allocated to active control (Ketoconazole). Randomization will determine which foot (right or left) will be treated with Dapaconazole or Ketoconazole.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-inferiority Phase II Trial Comparing BL123 (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dapaconazole
(cream; 2%; topical)
Drug: Dapaconazole
Active Comparator: Ketoconazole
(cream; 2%; topical)
Drug: Ketoconazole



Primary Outcome Measures :
  1. Clinical cure of the lesion(s) [ Time Frame: 14 days ]
    Assessment of presence or absence of lesion(s) by clinical examination

  2. Mycological cure of the lesion(s) [ Time Frame: 14 days ]
    Laboratory test for presence or absence of Tinea Pedis


Secondary Outcome Measures :
  1. Time (days) to clinical diagnosis of lesion(s) cure [ Time Frame: 14 days ]
  2. Time (days) to absence of itching at lesion(s) site [ Time Frame: 14 days ]

Other Outcome Measures:
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 45 days ]
    Number of adverse events

  2. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 45 days ]
    Changes of laboratory parameters that are out of normal values/ranges and/or considered as clinically significant by the investigator.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, aged between 18 and 60 years-old;
  • Presence of skin lesion(s) characteristic of Tinea Pedis, with diagnosis confirmed by direct mycological exam;
  • Absence of previous antifungic treatment for the current lesion(s) under study;
  • Absence of other significant diseases which, at physician's discretion, could have an impact on subject's participation in the trial, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate, physical examination and screening laboratory tests;
  • Ability to understand the nature and objectives of the trial, including its risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.

Exclusion Criteria:

  • Known hypersensitivity to ketoconazole or chemically related compounds; history of serious adverse reactions;
  • Current evidence of clinically significant diseases which, at physician's discretion, prevent subject's participation in the trial and/or expose the subject to risks other than what is normally expected;
  • Use of medications that, at principal investigator's discretion, might expose the subject to risks other than what is normally expected;
  • Screening laboratory tests results showing clinically relevant deviations that, due to potential risks, prevent participation in the trial, at the researcher's discretion;
  • Drugs addiction, including alcohol;
  • Use of any previous treatment to the lesion(s) under study that, according to principal investigator's discretion, might interfere with the study objectives;
  • Treatment, within 3 months before this trial, with any drugs known to have a well-established toxic potential to major organs;
  • Participation in any other experimental research or administration of any experimental drug within 6 months before this trial;
  • Positive pregnancy test, labor or miscarriage within 12 weeks before study treatment;
  • Any conditions, according to investigator's discretion, that prevent subjects to participate in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824926


Sponsors and Collaborators
Gilberto De Nucci
Biolab Sanus Farmaceutica
Investigators
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Principal Investigator: Gilberto De Nucci, PhD Galeno Desenvolvimento de Pesquisas Ltda.

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Responsible Party: Gilberto De Nucci, PhD, Galeno Desenvolvimento de Pesquisas Clínicas
ClinicalTrials.gov Identifier: NCT02824926    
Other Study ID Numbers: GDN 083/13
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: No IPD available.
Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors